Abstract
BackgroundThe Dynamic Locking Blade Plate (DLBP) was recently introduced for fixation of displaced femoral neck fractures (FNF) and has been well received. Although the results of this implant in young patients are promising, the DLBP has not yet been compared to a standard device such as the Dynamic Hip Screw (DHS). The aim of this study is to compare the clinical outcome and costs of displaced FNF treated with internal fixation by means of either the DLBP or the DHS in patients up to 65 years of age. We hypothesize that the DLBP is superior compared to the DHS in terms of revision surgery rate, union rate, incidence of avascular necrosis and implant related failure.MethodsThe DEFENDD (DisplacEd Femoral Neck fractures Dlbp versus Dhs) trial is a multicentre randomized controlled trial that will include 266 patients of 18–65 years with a displaced FNF. Patients will be randomized to receive either a DLBP or a DHS with a 1:1 allocation using a random block size, stratified for centre. Clinical follow up will last 1 year and questionnaires will be obtained up to 2 years. The main outcome parameter is the incidence of revision surgery within 1 year, due to either non-union, avascular necrosis (AVN) or cut out of the implant. Secondary study parameters are the incidence of avascular necrosis, non-union, (implant related) complications, functional outcome, elective removal of the implant and health-related quality of life and costs.DiscussionThe outcome of the DEFENDD trial will provide high-level evidence of which implant is favourable for the treatment of femoral neck fractures in young patients (≤65 years).Trial registrationNetherlands Trial Register, NL7300 Registration date 25-09-2018.
Highlights
The Dynamic Locking Blade Plate (DLBP) was recently introduced for fixation of displaced femoral neck fractures (FNF) and has been well received
We hypothesize that the DLBP is superior compared to the Dynamic Hip Screw (DHS) in terms of revision surgery rate, union rate, incidence of avascular necrosis and implant related failure
In this paper we present the rationale and design of a randomized controlled trial that compares the clinical outcomes of the DLBP and the DHS
Summary
The Dynamic Locking Blade Plate (DLBP) was recently introduced for fixation of displaced femoral neck fractures (FNF) and has been well received. The results of this implant in young patients are promising, the DLBP has not yet been compared to a standard device such as the Dynamic Hip Screw (DHS). Despite the frequent use of both these implants the failure rate of displaced FNFs is still high, with a non-union rate of 30–33% and an incidence of avascular necrosis (AVN) of 10–16% [3, 9,10,11]. The results of this study showed a failure rate of 4% [13] Another recent prospective cohort study of 106 patients of 60 years and younger with displaced FNF demonstrated a DLBP related failure rate of 13.2% [14]. Randomized controlled trials are needed to provide high-level evidence to determine the value of DLBP
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